|
CFSAN/Office of Food Additive Safety
February 18, 2007
| Date: | February 18, 2007 |
| From: | Environmental Toxicologist, Environmental Review Team (ERT)
Office of Food Additive Safety (HFS-246) |
| Subject: | FCN No. 687 - Decanedioic acid polymer with 2-hydroxypropanoic acid and 1,2 propanediol, block- for use as a modifier in polylactide (PLA) polymers |
| Notifier: | Dainippon Ink and Chemicals, Inc.
12 Yawatakaigandori Ichihara, Chiba 290-8585 JAPAN |
| To: | Division of Food Contact Notifications (HFS-275)
Attention: Vanee Komolprasert, Ph.D., P.E. Through: Layla I. Batarseh, Ph.D., Supervisor, ERT |
Attached are the Finding of No Significant Impact (FONSI) and our supplement to the environmental record for FCN 687. The food contact substance is decanedioic acid polymer with 2-hydroxypropanoic acid and 1,2-propanediol, block- for use as a modifier in the manufacture of polylactide (PLA) polymers for single-use food-contact articles. When this notification becomes effective, these documents and the notifier's environmental assessment (in PDF*, 551Kb), dated November 17, 2006, may be made available to the public in response to a FOIA request and we will post redacted copies of them on the internet at http://www.cfsan.fda.gov/~rdb/opa-envt.html.
Please let us know if there is any change in the identity or use of the food-contact substance.
Katrina E. White, Ph.D.
2 Attachments:
Finding of No Significant Impact
Supplement to the Environmental Record for Food Contact Notification No. 687
A food contact notification (FCN No. 687), submitted by Dainippon Ink and Chemicals, Inc., to provide for the safe use of decanedioic acid polymer with 2-hydroxypropanoic acid and 1,2-propanediol, block- for use as a modifier in the manufacture of polylactide (PLA) polymers for single-use food-contact articles.
The Environmental Review Team has determined that allowing this notification to become effective will not significantly affect the quality of the human environment and therefore will not require the preparation of an environmental impact statement. This finding is based on information submitted by the notifier in the notification, including an environmental assessment (in PDF*, 551Kb), dated November 17, 2006, and our supplement to the environmental record for FCN 687.
Prepared by__________________________________________Date: February 18, 2007
Katrina E. White, Ph.D., Environmental Toxicologist
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration
Approved by__________________________________________Date: February 18, 2007
Layla I. Batarseh, Ph.D., Supervisor
Environmental Review Team
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
Food and Drug Administration
This document incorporates by reference the notifier's revised environmental assessment (EA) (in PDF*, 551Kb), dated November 17, 2006.
The purpose of this supplement is to ensure the accuracy and completeness of the environmental record and to assist the public in understanding the agency's basis for preparing a finding of no significant impact (FONSI) for the proposed use.
Item 4. Description of the Proposed Action.
The EA states under Item 4, "Food contact films imported, brand labeled and sold by the US user will be utilized in patterns corresponding to the national population density and will be widely distributed across the country. Therefore, it is anticipated that disposal will occur nationwide, with about 76% of the materials being deposited in land disposal sites, and about 24% combusted." Municipal solid waste trends have recently been updated and we summarize them below. In 2005, 54.3% of all municipal solid waste in the United States was deposited in land disposal sites, 13.6% was combusted with energy recovery, and 32.1% was recovered for composting and recycling (1). Materials that are composted include yard trimmings, food scraps, and other organic material (1). Plastics, including the FCS and biodegradable plastics, are not commonly composted or recycled to a significant extent (1,2). Of the municipal solid waste that was not recovered for composting and recycling, (33,400,000 tons combusted + 133,310,000 tons landfilled = 166,710,000 tons), 20% was combusted with energy recovery and 80% was land disposed (1). It is also expected that 20% of the FCS will be combusted and 80% will be land disposed.
Item 6. Introduction of Substances into the Environment.
The EA states under Item 6, "Combustion products are expected to be carbon dioxide and water. Thus, no toxic combustion products are expected as a result of the proper incineration of the copolymer." Combustion of the food-contact substance (FCS), as combustion of all solid waste, will result in the generation of toxic substances such as carbon monoxide, carbon dioxide, carbon (soot), particulate matter, and hydrocarbons (3). However, we believe that in a properly operating incinerator, such compounds are unlikely to be emitted into the environment at quantities that would significantly alter current emissions from municipal solid waste combustion facilities (3). The FCS is composed of carbon, hydrogen, and oxygen, elements that are commonly found in municipal solid waste. The molecular structure of the FCS and the market volume (available in a confidential attachment to the food-contact notification) show that 1) the FCS will make up a very small portion of the total municipal solid waste currently combusted (estimated to be 33 million tons or 14% of 296 million tons in 2005) (1), and 2) the FCS will not significantly alter the emissions from properly operating municipal solid waste combustors (3). Therefore, incineration of the FCS will not cause municipal solid waste combustors to threaten a violation of applicable emissions laws and regulations (40 CFR part 60 and/or relevant state and local laws).
Item 7. Fate of Emitted Substances in the Environment.
The EA states under Item 7, "The products of complete combustion of the polymer would be carbon dioxide and water; the concentrations of these substances in the environment will not be significantly altered by the proper incineration of the polymer in the amounts utilized for food packaging applications." We agree that the proper incineration of the FCS will not significantly alter current emissions from properly operating incinerators. However, some incomplete combustion will occur and emissions other than those listed are expected (3).
The EA also states under Item 7, "No significant quantities of any substance will be added to these water systems upon the proper incineration of the polymer, nor upon its disposal in landfills due to the extremely low levels of aqueous migration of polymer components." We do not agree completely with this statement. The main reason that the fate of the FCS in the aqueous environment did not need to be addressed is because no significant introductions of substances into the environment were identified under Format Item 6. Additionally, in general, migration studies on these food-packaging materials, which are performed to demonstrate the safety of polymeric packaging, indicate only low levels of migration of substances from the package into food. This supports the premise that the FCS is unlikely to leach from the food-package into the landfill leachate. Even if small amounts of the FCS migrate into the landfill leachate, it is unlikely they will migrate out of the landfill because of the Environmental Protection Agency's (EPA) regulations governing municipal solid waste landfills. EPA's regulations require new municipal solid-waste landfill units and lateral expansions of existing units to have composite liners and leachate collection systems to prevent leachate from entering ground and surface water, and to have ground-water monitoring systems (see 40 CFR Part 258). Although owners and operators of existing active municipal solid waste landfills that were constructed before October 9, 1993 are not required to retrofit liners and leachate collections systems, they are required to monitor groundwater and to take corrective action as appropriate.
Literature Cited
1. Municipal Solid Waste in the United States: 2005 Facts and Figures; EPA530-R-06-011; U.S. Environmental Protection Agency; Office of Solid Waste: Washington, D.C., Oct, 2006. http://www.epa.gov/msw/msw99.htm (accessed Feb. 8, 2007).
2. Making packaging greener - biodegradable plastics, http://www.science.org.au/nova/061/061key.htm (accessed Feb. 8, 2007).
3. Sullivan, P. M.; Hallenbeck, W. H.; Brenniman, G. R. Municipal Solid Waste Combustion; University of Illinois at Chicago: Chicago, IL, 1993.
Prepared by__________________________________________Date: February 18, 2007
Katrina E. White, Ph.D., Environmental Toxicologist
Environmental Review Team
Office of Food Additive Safety
*PDF Readers are available for free from the Adobe Acrobat web site.
